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Method for purifying teriparatide acetate

A technology of teriparatide and purification method, applied in the field of purification of teriparatide acetate, can solve the problems of low yield, unfavorable industrial production and the like, and achieve the effects of high yield, improved quality and high purity

Active Publication Date: 2013-03-27
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Prior art CN102731643A discloses a purification method of teriparatide, using water as a solvent, then using a C18 column as a mobile phase with 0.2% TFA / acetonitrile to purify, and then using a 0.2% acetic acid / acetonitrile C18 column to transfer salt, although Higher purity teriparatide acetate can be obtained, but the total yield is only about 20%, which is not conducive to industrial production
[0005] In order to solve the problem of low yield in the prior art, improve the purification yield of teriparatide acetate, and reduce production costs, further research on the purification method is required

Method used

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  • Method for purifying teriparatide acetate

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Experimental program
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Effect test

Embodiment 1

[0030] 1. Sample processing:

[0031] The volume ratio was dissolved in the coarse peptide at a concentration of not greater than 50g / L at a concentration of 10%-30%and 5%-20%.

[0032] 2. Purification:

[0033] Purification conditions: chromatographic column: chromatographic column with eighteen alkane kel silicone as a fixed phase, the diameter and length of the column are: 5 cm × 25 cm.Flow phase: A phase: 0.3%sulfuric acid and 0.2%acetic acid acetic acid solution (V / V), adjust the pH value of 6.0 with ammonia aquatic solution; B phase: acetylene, flow velocity: 50-80 ml / min, gradient B%: 20%-40%, Detection wavelength: 280 nm.The sample volume is 2.5g.

[0034] Purification process: Rinse the color spectrum pillar with more than 50%acetylene, and then balance the sample with a sample of 2.5g.The linear gradient was eluted for 60min, collecting the target peak, and the collective degree of the collecting of the Condippeptide solution was greater than 95%at the condition that the...

Embodiment 2

[0040] 1. Sample processing:

[0041] The volume ratio was dissolved in the coarse peptide at a concentration of not greater than 50g / L at a concentration of 10%-30%and 5%-20%.

[0042] 2. Purification:

[0043] Purification conditions: chromatographic column: chromatographic column with eighteen alkane kel silicone as a fixed phase, the diameter and length of the column are: 10 cm × 25 cm.Flow phase: A phase: 0.3%sulfuric acid and 0.2%acetic acid acetic acid solution (V / V), adjust the pH value of 5.5 with ammonia water solution; B phase: acetylene, flow rate: 150-250 ml / min, gradient B%: 20%-40%, Detection wavelength: 280 nm.The sample volume is 10g.

[0044] Purification process: Rinse the color spectrum pillar with more than 50%acetylene, and then balance the sample with a sample of 10g.The linear gradient was eluted for 60min, collecting the target peak, and the collective degree of the collecting of the Condippeptide solution was greater than 95%at the condition that the pres...

Embodiment 3

[0050] 1. Sample processing:

[0051] The volume ratio was dissolved in the coarse peptide at a concentration of not greater than 50g / L at a concentration of 10%-30%and 5%-20%.

[0052] 2. Purification:

[0053] Purification conditions: chromatographic column: chromatographic column with eighteen alkane kel silicone as a fixed phase, the diameter and length of the column are: 15 cm × 25 cm.Flow phase: A phase: 0.3%sulfuric acid and 0.2%acetic acid acetic acid solution (V / V), adjust the pH value of 5.0 with ammonia aquatic solution; B phase: acetylene, flow rate: 350-600 ml / min, gradient B%: 20%-40 — 40%, Detection wavelength: 280 nm.The sample volume is 25g.

[0054] Purification process: Rinse the color spectrum pillar with more than 50%acetylene, and then balance the sample with a sample of 25g.The linear gradient was eluted for 60min, collecting the target peak, and the collective degree of the collecting of the Condippeptide solution was greater than 95%at the condition that t...

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Abstract

The invention provides a method for purifying teriparatide acetate, comprising the following steps: dissolving crude peptide by using the aqueous solution of 10-30% of acetic acid and 5-20% of acetonitrile in volume ratio; carrying out gradient elution and purification on a crude peptide solution; adjusting the pH value of the aqueous solution of 0.1-0.4% of sulfuric acid and 0.1-0.4% of acetic acid in volume ratio by using ammonia water to be 5.0-6.0; obtaining the solution as phase A and acetonitrile as phase B; eluting when the gradient of the phase B is 20-40%; salting out; washing by using an ammonium acetate solution containing 3-10% of acetonitrile; converting acetate by using the high performance liquid chromatography of the octadecylsilane chemically bonded silica gel; and eluting an acetic acid aqueous solution acetonitrile system. The invention aims to provide a method for purifying the teriparatide acetate, which is simple in operation, high in yield and purity, and favorably realizes industrialization.

Description

Technical field [0001] The present invention involves a purification method of a polypeptide, especially the purification method of Typappeptide acetate. Background technique [0002] TERIPARATIDE, English name, molecular format C 181 H 292 N 55 O 51 S 2 EssencePTH (PTH (1-34)) is a 34 peptide, also known as human thyroid gonadotropin (1-34).Turpan peptide is a polypeptide composed of 1-34 amino acids composed of 1-34 amino acids (HUMAN) amino acids (Human).In 2002, it was approved by the US FDA.It is the first bone propagant agent approved to treat severe osteoporosis, and has a wide range of market application prospects. [0003] At present, there are many literatures and patents that are synthesized by Curpa peptide, but they involve less purification, especially the large -scale purification preparation of the combination of anti -phase chromatography and salt analysis of the present invention (a batch of more than 200 grams of boutique boutique 200 grams or more) High purity...

Claims

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Application Information

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IPC IPC(8): C07K14/635C07K1/36C07K1/34C07K1/20
Inventor 赵忠卫刘建马亚平袁建成
Owner HYBIO PHARMA
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